The present invention relates generally to methods for analyzing, evaluating, and controlling risk of language translation errors in connection with medical device labeling, and, more specifically, to risk managing methods that identify the inherent risk level of the device; identify the safety functions of the content that is translated; evaluate the risks associated with the translation process; and analyze this risk information and apply it in the selection of resources and in the design and execution of processes to mitigate the risk of safety-related translation errors effectively.